Associate Director, Quality Assurance

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Stellenbeschreibung:

Responsibilities

Serve as team lead to internal QA team members
Lead QA oversight of CDMO and internal QA activities, ensuring compliance with regulatory/GMP expectations and established Quality Agreements
Support and maintain vendor assessment activities
Provide quality management of vendors using risk-based decision-making during manufacturing and testing activities
Support quality performance and continuous improvement activities
Oversee quality of third-party supplier services, including manufacturing, filling, packaging, and shipping as appropriate
Maintain regular oversight through periodic monitoring, auditing, and Quality Agreement reviews
Manage Data Verification activities to ensure data integrity and compliance with GDP
Identify opportunities to improve quality systems and clinical-to-commercial operational processes and drive implementation to completion
Develop, monitor, and report quality metrics and KPIs to support Quality Management Review
Support quality systems, including internal and external deviations and change controls
Assess product, compliance, and operational risks and partner with cross-functional teams to develop and implement risk management strategies
Review and approve controlled documents
Perform other duties as assigned

Requirements

Bachelor’s degree in Biology, Chemistry or other relevant scientific discipline preferred
8-10 years of cGMP Quality Assurance experience with cell therapy, biologics, and/or small molecule programs
5+ years of experience directly managing a team of direct reports within QA
Commercial QA experience a plus
Travel required up to 35%
Experience with eQMS (e.g., ACE, TrackWise)
Working knowledge of current industry practices and standards in an FDA-regulated biotechnology company
Excellent record keeping and documentation skills
Strong verbal and written communication skills, with the ability to concisely present information in cross-functional settings
Experience working with CDMOs preferred
Proficient use of MS Office products
Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all cGMP and regulatory requirements are met
Ability to work effectively both independently and with other team members

Core Competencies

Demonstrates expertise in Quality Assurance with a focus on cGMP compliance, risk management, and vendor quality oversight. Proven ability to lead teams, manage quality metrics, and implement continuous improvement initiatives in a regulated biotechnology environment.